Achieving international consensus on the assessment of psoriatic arthritis in psoriasis clinical trials: an International Dermatology Outcome Measures (IDEOM) initiative
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Psoriatic arthritis (PsA) is rarely assessed in psoriasis randomized controlled trials (RCT); thus, the effect of psoriasis therapy on PsA is unknown. The International Dermatology Outcome Measures (IDEOM) has included “PsA Symptoms” as part of the core domains to be measured in psoriasis RCT. This study aimed to achieve consensus about screening for PsA and how to measure for “PsA Symptoms” in psoriasis RCT. At the IDEOM 2017 Annual Meeting, stakeholders voted on the role of PsA screening in psoriasis RCT. To select measures for “PsA Symptoms”, we adapted the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines. Three potential measures were selected. At the meeting, stakeholders voted on the validity, feasibility, and responsiveness of these measures. Of the 47 stakeholders, 93% voted that all psoriasis trial participants should be screened for PsA. “PsA Symptoms” measures included Patient Global (PG)-arthritis, Routine Assessment Patient Index Data (RAPID)-3, and Psoriatic Arthritis Impact of Disease (PsAID)-9. During the voting, more than 50% of the voters agreed that RAPID3 and PsAID9 were good measures for PsA Symptoms, able to capture all its essential elements. PsAID9 was considered the most feasible instrument, followed by RAPID3 and PG-arthritis, respectively. Finally, most participants agreed that RAPID3 and PsAID9 were responsive measures. Most study participants voted that all subjects in a psoriasis clinical trial should be screened for PsA. RAPID3 and PsAID9 outperformed PG-arthritis in measuring PsA Symptoms. This will be followed by a Delphi survey involving a larger stakeholder group.
KeywordsPsoriatic arthritis Patient-reported outcome measures Clinical trials Psychometric Screening
We thank Dr. Philip Mease for his collaboration in the design of the Delphi Survey during the 2018 GRAPPA adjacent to the AAD Meeting in San Diego, CA, USA.
This study was funded by the International Dermatology Outcome Measures group.
Compliance with ethical standards
Conflict of interest
Dr. Gottlieb is an advisor/consultant for Janssen Inc.; Celgene Corp., Bristol Myers Squibb Co., Beiersdorf, Inc., Abbvie, UCB, Novartis, Incyte, Pfizer, Lilly, Xenoport, Development Crescendo Bioscience, Aclaris, Amicus, Reddy Labs, Valeant, Dermira, Allergan, CSL Behring, Merck, Sun Pharmaceutical Industries. Also, she received research/educational grants from Janssen, Incyte. Dr. Duffin has been a consultant and/or investigator for Amgen, Janssen, Lilly, Novartis, Celgene, Pfizer; Bristol-Myers Squibb Co. Dr. Garg served on the advisory board of Abbvie, Janssen, and Pfizer receiving honoraria. Also, he received research/educational grants from AbbVie and Merck. Dr. Armstrong has served as investigator, advisor and/or consultant to AbbVie, Janssen, Novartis, Lilly, Regeneron, Sanofi, Science 37, Modernizing Medicine, and Valeant. Dr. Merola has served as an advisor/consultant for Biogen IDEC, AbbVie, Amgen, Eli Lilly, Novartis, Pfizer, Janssen, UCB, Kiniksa, Momenta and Mallinckrodt. He has been a speaker for AbbVie and Eli Lilly, and an investigator for Biogen IDEC, Amgen, Pfizer and Boehringer Ingelheim. Dr. Ogdie served as a consultant for Bristol-Myers Squibb, Lilly, Novartis, Pfizer, and Takeda and has received grant funding to the University of Pennsylvania from Pfizer (co-investigator) and Novartis. John Latella has served as Patient Consultant for Boehringer Ingelheim, and Patient Advocate for GfK. Dr. Perez-Chada has received research funding from “RADLA Scholarship 2010”. The other authors have no disclosures.
Research involving human participants and/or animals
Evaluation by an ethical board was deemed exempt given the nature of a consensus meeting. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Process to obtain informed consent was deemed exempt given the nature of a consensus meeting.
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